Validated Solution to (CPET) Clinical Data
The customer sought assistance to create and qualify a custom CPET Analysis Workbook (CPET Workbook). Discrete steps and activities were required to create and collectively demonstrate the CPET Workbook's capability to meet the defined business and regulatory requirements and provide a high degree of confidence in the design and deployment of the CPET Workbook.
The Situation
- Customer required a validated solution to analyze their cardiopulmonary exercise test (CPET) clinical data.
- Customer’s previous solution required manual manipulations, calculations, and data transcriptions.
- Customer’s QC verification of data often uncovered human error.
- Customer received inconsistently formatted data from investigator sites.
- Customer’s workbook had various anomalies and required modifications to analyze data set types.
The Solution
- USDM created a customized CPET analysis workbook that:
- Had formulas and macros for importing raw CPET data
- Converted data to rolling averages
- Calculated endpoints according to study protocol
- USDM validated the custom CPET analysis workbook
- USDM secured the workbook with locked formulas and macros
- USDM automated the workbook’s calculations
- USDM decreased the customer’s QC verification time and effort by 75%
- USDM decreased the customer’s analysis time by 25%
The Results
- 75% decrease in QC verification time and effort
- 25% decrease in analysis time
- Customized, automated, and validated workbook delivered